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EP1884200B1 - Nahtschleifenkonstrukt mit frei beweglicher Nadel - Google Patents

Nahtschleifenkonstrukt mit frei beweglicher Nadel Download PDF

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Publication number
EP1884200B1
EP1884200B1 EP07450132A EP07450132A EP1884200B1 EP 1884200 B1 EP1884200 B1 EP 1884200B1 EP 07450132 A EP07450132 A EP 07450132A EP 07450132 A EP07450132 A EP 07450132A EP 1884200 B1 EP1884200 B1 EP 1884200B1
Authority
EP
European Patent Office
Prior art keywords
suture
needle
loop
tissue
graft
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP07450132A
Other languages
English (en)
French (fr)
Other versions
EP1884200A3 (de
EP1884200A2 (de
Inventor
Jacob Jolly
Matthew C. Summit
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Arthrex Inc
Original Assignee
Arthrex Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Arthrex Inc filed Critical Arthrex Inc
Publication of EP1884200A2 publication Critical patent/EP1884200A2/de
Publication of EP1884200A3 publication Critical patent/EP1884200A3/de
Application granted granted Critical
Publication of EP1884200B1 publication Critical patent/EP1884200B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/1146—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of tendons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06019—Means for attaching suture to needle by means of a suture-receiving lateral eyelet machined in the needle

Definitions

  • the present invention relates to a needle/suture assembly, comprising at least one continuous suture loop and a needle attached to the at least one continuous suture loop.
  • Suture strength is an important consideration in any surgical suture material.
  • One of the strongest materials currently formed into elongated strands is an ultrahigh molecular long chain weight polyethylene, typically used for fishing line and the like, which is sold under the trade names Dyneema or Spectra.
  • WO 00/54666 discloses a free standing suture loop element provided with two needle suture breakaway elements. The breakaway elements are used to pierce tissue and draw the free standing suture loop element there through during the attachment or reattachment procedure.
  • Rep 1168 967 B1 discloses a steel needle with a loop of Nylon suture material, which loop may be formed by knotting the two ends of the Nylon suture material.
  • the document furthermore discloses to pass the needle through the tissue being sutured and thereafter through the loop pulling the leading part through and beyond the trailing part of the loop. Thereafter a suture clip is used to prevent movement of one section relative to the other. Excess suture material beyond the suture clip may be cut off and discarded or over reused. Knotting the two ends of the suture material enables to form a continuous loop of suture for a fixation with a clamp, but causes problems for other ways to secure soft tissue.
  • the present invention provides a system for graft preparation and/or tissue repair employing a continuous loop of suture attached to a free floating needle according to independent claim 1.
  • the free floating needle is not swaged on the suture so that, after passing the suture loop construct through the graft or the tissue to be treated, the needle may be recentered if the suture strands are uneven.
  • Figure 1 illustrates a construct in accordance with the present invention, the construct having a continuous loop of suture attached to a free floating needle;
  • Figure 2 illustrates another view of the suture loop/needle construct of Figure 1 ;
  • Figure 3 illustrates a processing step for preparing a whip stitched graft construct employing the suture loop/needle construct of Figure 1 ;
  • Figure 4 illustrates a processing step for preparing the whip stitched graft construct, and at a subsequent step to that shown in Figure 3 ;
  • Figure 5 illustrates a processing step for preparing the whip stitched graft construct, and at a subsequent step to that shown in Figure 4 ;
  • Figure 6 illustrates a processing step for preparing the whip stitched graft construct, and at a subsequent step to that shown in Figure 5 ;
  • Figure 7 illustrates a processing step for preparing the whip stitched graft construct, and at a subsequent step to that shown in Figure 6 ;
  • Figure 8 illustrates a processing step for preparing the whip stitched graft construct, and at a subsequent step to that shown in Figure 7 ;
  • Figure 9 illustrates a processing step for preparing the whip stitched graft construct, and at a subsequent step to that shown in Figure 8 .
  • the present invention provides a suture loop/needle construct with a free floating needle and increased strength.
  • An exemplary method of employing such suture loop/needle construct in surgery is also disclosed.
  • the suture loop/needle construct of the present invention may be employed for threading suture through or around a first tissue (for example, a graft) with maximum suture fixation strength.
  • the first tissue may be further secured to a second tissue that allows for accelerated healing.
  • the first tissue may comprise at least one of (i) biological tissue, such as soft tissue (for example, tendon, ligament, graft, or combination thereof) or hard tissue (for example, bone); and/or (ii) non-biological tissue.
  • the second tissue may also comprise at least one of (i) biological tissue, such as soft tissue (for example, tendon, ligament, graft, or combination thereof) or hard tissue (for example, bone); and/or (ii) non-biological tissue.
  • the second tissue may comprise tissue that is similar to or different from the first tissue.
  • the first tissue may be a portion of a torn ligament, while the second tissue may be bone, or a different portion of the same torn ligament, or a non-biological tissue construct such as a fixation device.
  • FIG. 1 and 2 illustrate a suture/needle construct 100 of the present invention.
  • the suture/needle construct 100 comprises at least one continuous loop of suture 10 (preferably a continuous loop of #2 FiberWire suture 1 (as described below) that is attached to a free floating needle 20.
  • the continuous loop of suture 10 of the present invention may be formed of any flexible material.
  • the continuous loop is formed of a high strength suture material such as Arthrex FiberWire suture, which is described in U.S. Pat. No. 6,716,234 to Grafton et al.
  • FiberWire suture is formed of an advanced, high-strength fiber material, namely ultrahigh molecular weight polyethylene (UHMWPE), sold under the trade names Spectra (Honeywell) and Dyneema (DSM), braided with at least one other fiber, natural or synthetic, to form lengths of suture material.
  • UHMWPE ultrahigh molecular weight polyethylene
  • DSM Dyneema
  • the FiberWire suture may include a core within a hollow braided construct, the core being a twisted yam of UHMWPE.
  • the suture may optionally include filaments of various colors.
  • each suture loop of the plurality of suture loops may be attached individually to the needle 20.
  • the perimeter of each suture loop is preferably fixed and the suture loops may have similar dimensions.
  • free floating needle 20 is a very thin metal needle (preferably nitinol or stainless steel) that allows an increased number of suture loop passes through or around the tissue to be sutured or attached, with decreased trauma.
  • the free floating needle 20 is not swaged on the suture loop 10 so that, after passing the suture loop 10 through the tissue to be treated, needle 20 may be recentered if the suture strands are uneven. In this manner, the tissue to be treated is maintained intact and, in turn, a stronger tissue/suture construct is formed.
  • the free floating needle 20 can be manufactured much thinner (about 1 to about 3mm diameter, more preferably of about 2mm diameter) than the conventional swaged on needles. A thinner needle is much less traumatic, keeping tissue intact and allowing an increased number of passes through tissue.
  • Free floating needle 20 may be attached directly or indirectly to the suture loop 10 (or, as noted above, to a plurality of suture loops).
  • needle 20 is attached to the suture loop 10 through an eyelet or loop 22, which may be formed integral to the needle 20 (during manufacturing) or attached to the needle 20 after the formation of the needle.
  • Loop 22 may have various shapes and may be formed of various materials (for example, nitinol or suture, preferably a high strength suture material) and may have various dimensions that allow the needle 20 to freely move around the perimeter of suture loop 10. Needle 20 need not be straight and may have various shapes or configurations (for example, curved, or a combination of straight and curved), depending on the characteristics of the surgical procedure involved.
  • the suture/needle construct 100 may be provided with free floating needle 20 having a first length L 1 and suture loop 10 having a second length L 2 , which may be similar to or different from the first length L 1 of the needle 20.
  • needle 20 may have a length L 1 of about 3cm (for a needle with a diameter of about 3mm), whereas the length L 2 of the suture loop may be of about 5cm (for a suture with a diameter of about 2.5mm).
  • the suture loop/needle construct of the present invention may be provided with a free floating needle 20 attached to a chain of suture loops, preferably of braided high strength suture loops, for surgical applications, such as disclosed in U.S. Pat. Publication No. 2007/0135843 .
  • the suture chain can comprise a series of closed loops of suture formed in a conventional "chain.”
  • at least one of the loops or “links" of the chain can be formed first by "piercing” or "lacing" an end of the suture through a standing part of the suture, to form an initial suture "intersection" in a first direction (for example, in the x-y direction).
  • the suture intersection is then locked by lacing the end through the suture intersection in a second direction (for example, in the z direction), piercing both strands at the center of the initial junction, and pulling the strands tight.
  • Successive loops or links may be developed along the length of suture in similar fashion to form a suture chain.
  • the loops of the chain can be, but need not be, interlinked, and the chains of the present invention can include two or more loops that are connected together. Each loop preferably has a fixed perimeter. All loops may be similar in size.
  • At least one (preferably all) of the loops of the chain may be formed of high-strength suture such as FiberWire.
  • the suture loops of the suture chain may also comprise suture that may optionally include filaments of various colors.
  • the tissue to be treated is a soft tissue graft prepared for tissue fixation by stitching the graft, for example, with the suture loop/needle construct 100 of the present invention.
  • single tendon strands may be sutured together by passing the suture loop/needle construct 100 of the present invention over the graft. It is understood that treatment (such as suturing or attachment, for example) of any tissue may be performed with the suture loop/needle construct 100 described above.
  • FIGS 3-9 illustrate an exemplary method of stitching a soft tissue graft comprising single tendon strands that are sutured together by passing the suture loop/needle construct 100 of the present invention over the graft.
  • the suture loop/needle construct 100 may be passed over a free end of the graft tendons, with the needle 20 being passed through the graft tendons at a starting point (which, in an example, is located at about the center of the graft tendons).
  • the graft tendons may be stitched together starting from the center and moving toward the end of the graft.
  • Figure 3 illustrates a working station with a preparation area having a soft tissue graft comprising single tendon strand 30 folded in half at end 111 of the preparation area, so that regions 110, 120 of the tendon strand are securely affixed to the end 111.
  • opposite ends 112 of the graft tendon regions are held by hand and/or by employing a clamp, for example.
  • the opposite ends 112 of the graft can be also affixed to the preparation area but in a way that allows the graft to be easily released to pass a suture loop over the graft.
  • a flexible strand is provided in the vicinity of the preparation area and of the graft.
  • the flexible strand may be strand 10 of the suture loop/needle construct 100 (preferably a continuous loop of #2 FiberWire suture attached to free floating thin needle 20).
  • the thin needle is preferably straight and easy to handle, without instruments.
  • the needle moves freely on the suture 10 to recenter itself after passing through tissue and to facilitate even tensioning.
  • the free floating needle 20 is not swaged on the suture 10 so, after passing the suture loop construct 100 through the tissue to be treated, the needle 20 may be recentered if the suture strands are uneven.
  • Flexible suture loop 10 attached to free needle 20 is passed over the free ends 112 of the graft tendon, as shown in Figure 4 .
  • the needle is then passed through the graft tendon regions 110, 120 at a proximal starting point which, in an exemplary embodiment only, is located at about the center of the graft tendon regions ( Figure 5 ).
  • the graft tendon regions will be stitched together starting from the center and moving toward the ends 112 of the graft.
  • the suture strands are spread on either side of the graft, dropping the graft between the strands.
  • the needle 20 is then passed through the graft tendon regions, distal to the first pass (i.e., towards the ends 112 of the graft tendon regions), as shown in Figure 8 .
  • the needle 20 is inserted on the same side of the graft with each pass.
  • the graft may be provided with a first stitched region 50 ( Figure 9 ) of the graft (comprising single tendon strands sutured together) which is adjacent a second region of the graft (comprising segments of the single tendon strands that are not tied together).
  • needle 20 may be cut off and the suture loop maintained or, alternatively, cut more proximal to give two free ends of suture. If a last minute length change to the stitched area of the graft is needed, then the distal passes of suture may be unthreaded and the graft cut to size.
  • Stitched tissue for example, stitched tissue graft such as tendon graft
  • Stitched tissue prepared employing the suture loop/needle construct 100 of the present invention may be used for reattachment or fixation with a fixation device (such as an interference screw, for example) for ligament reconstruction.
  • a fixation device such as an interference screw, for example
  • Suture loop/needle construct 100 is employed to simply put stitches in the graft and prepare the stitched or sutured graft for further surgical procedures (for example, ligament reconstruction and fixation to a fixation device such as interference screw).
  • any tissue for example, suturing or attachment of biological tissue like cartilage, tendon, etc.
  • treatment of any tissue may be performed with the suture loop/needle construct 100; and/or treatment of a first tissue (for example, bone, tendon, ligament, fixation device, etc.) relative to a second tissue (for example, bone, tendon, ligament, fixation device, etc.), the first tissue being similar to, or different from, the second tissue.
  • tissue repairs such as ligament repair, i.e., simple suturing of tissue, tendon to tendon repair, graft to bone repair, or tendon to bone repair, among others, may be performed with the suture loop/needle construct 100 of the present invention.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)

Claims (10)

  1. Eine Nadel-/Nahtanordnung (100), umfassend:
    zumindest eine durchgängige Nahtschleife (10); und
    eine an der zumindest einen durchgängigen Nadelschleife (10) befestigte Nadel (20), gekennzeichnet dadurch, dass die durchgängige Nadelschleife (10) durch Schnürung gebildet wird, so dass die Schleife nicht unterbrochen ist und dass die Nadel (20) eine eine Öse (22) umfassende frei bewegliche Nadel ist und dass die durchgängige Nadelschleife (10) an der Nadel (20) durch die Öse (22) befestigt ist, die so ausgeführt ist, dass die Nadel (20) frei um einen Umfang der zumindest einen Nahtschleife (10) bewegt werden kann und sich selbst wieder mittig auf der durchgängigen Nadelschleife positionieren kann.
  2. Die Nadel-/Nahtanordnung nach Anspruch 1, worin die Nahtschleife (10) aus einem Nahtmaterial gebildet ist, das ultrahochmolekulares Polyethylen umfasst.
  3. Die Nadel-/Nahtanordnung nach Anspruch 1, worin die frei bewegliche Nadel (20) eine Nitinolnadel ist.
  4. Die Nadel-/Nahtanordnung nach Anspruch 1, worin die frei bewegliche Nadel (20) einen Durchmesser von etwa 1 mm bis etwa 3 mm aufweist.
  5. Die Nadel-/Nahtanordnung nach Anspruch 1, weiters umfassend eine Vielzahl von Nahtschleifen (10).
  6. Die Nadel-/Nahtanordnung nach Anspruch 5, worin zumindest eine der Vielzahl von Nahtschleifen (10) einen Umfang aufweist, der etwa gleich wie jener einer weiteren Vielzahl von Nahtschleifen (10) ist.
  7. Die Nadel-/Nahtanordnung nach Anspruch 1, worin die durchgängige Nahtschleife (10) ein Glied einer Nahtkette ist, umfassend einen Nahtstrang mit zumindest zwei Nahtschleifen (10).
  8. Die Nadel-/Nahtanordnung nach Anspruch 7, worin die Nahtkette aus einem Nahtmaterial gebildet ist, umfassend ultrahochmolekulares Polyethylen.
  9. Die Nadel-/Nahtanordnung nach Anspruch 7, worin die frei bewegliche Nadel (20) eine gekrümmte oder gerade Konfiguration aufweiset.
  10. Die Nadel-/Nahtanordnung nach Anspruch 7, worin die frei bewegliche Nadel (20) eine Länge von etwa 3 cm und die Nahtkette einen Umfang von etwa 10 cm aufweist.
EP07450132A 2006-07-31 2007-07-31 Nahtschleifenkonstrukt mit frei beweglicher Nadel Active EP1884200B1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US83419106P 2006-07-31 2006-07-31

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EP1884200A2 EP1884200A2 (de) 2008-02-06
EP1884200A3 EP1884200A3 (de) 2008-08-13
EP1884200B1 true EP1884200B1 (de) 2010-08-25

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US (1) US8591544B2 (de)
EP (1) EP1884200B1 (de)
AT (1) ATE478609T1 (de)
DE (1) DE602007008648D1 (de)

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Also Published As

Publication number Publication date
ATE478609T1 (de) 2010-09-15
EP1884200A3 (de) 2008-08-13
DE602007008648D1 (de) 2010-10-07
US20080027485A1 (en) 2008-01-31
US8591544B2 (en) 2013-11-26
EP1884200A2 (de) 2008-02-06

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